Surgical Site Infections
Conditions
Keywords
negative pressure wound management system, open-heart surgery, antibiotic prophylaxis, surgical site infection
Brief summary
This vanguard study will be conducted at two study sites in Canada. It is a cluster randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure wound management system (Prevena) versus standard wound dressing to reduce chest wound infections.
Detailed description
Despite the routine use of antibiotics before and after cardiac surgery, infections of the chest wound remain a common life threatening complication of heart surgery that is preventable. Antibiotic prophylaxis is well accepted to be the cornerstone of prevention for these infections. The best choice of antibiotic prophylaxis in patients undergoing open heart surgery is, however, unclear. A large number of relevant pathogens are not covered by the primarily recommended antibiotic for prophylaxis, and there is a large variability in the antibiotics physicians use in practice and a lack of evidence supporting these choices. Appropriate management of the wound is probably also highly relevant in terms of infection prevention; however, there is a lack of strong evidence guiding the choice of wound management strategies as a means to reduce surgical site infection. The proposed study will test whether dual antibiotic prophylaxis is superior to single-agent prophylaxis with cefazolin, and shed light on whether or not modern negative-pressure wound management technology lower the risk of sternal surgical site infections.
Interventions
Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.
DEVICEPrevena
Negative-Pressure Wound Management System
DRUGCefazolin
antibiotic
DRUGVancomycin
antibiotic
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded adjudication of the s-SSIs will be performed by a committee consisting of three members.
Intervention model description
1\) cefazolin prophylaxis plus Prevena\*(\*diabetic and/or obese patients (BMI \>30kg/m2)) 2) cefazolin and vancomycin prophylaxis plus Prevena\*(\*diabetic and/or obese patients (BMI \>30kg/m2)), 3) cefazolin prophylaxis plus standard wound dressing, 4) cefazolin and vancomycin prophylaxis plus standard wound dressing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- ≥18 years of age undergoing open-heart surgery (sternotomy, including minimally-invasive sternotomies)
Exclusion criteria
* On systemic antibiotics or with an active bacterial infection at the time of surgery * Patients previously enrolled in this trial * Patients known to be colonized with Methicillin-resistant S. aureus (MRSA)(unethical not to administer glycopeptides), beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively, or to silver precluding the use of Prevena * Participation in other studies that may interfere with this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the wound management system | Prevena or standard wound dressing applied after surgery as per protocol, assessed up to 90 days after surgery | goal is \>90% |
| Adherence to the antibiotic regimen | Cefazolin: within an hour of surgery; one intra-operative dose at 4 hours after the first dose or upon wound closure (whatever comes first); two post-operative doses q8h. Vancomycin: initially intravenously; second dose 12 hrs after the first dose. | goal is \>90% |
| Loss of follow-up | up to 90 days after surgery | goal is \<10% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality in patients with an active infection | up to 90 days after surgery | using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions |
| ICU (Intensive Care Unit) and hospital stay | Length of ICU - from date of surgery to initial ICU discharge date, assessed up to 90 days after surgery. Hospital Stay - date of surgery to date of hospital discharge, assessed up to 90 days after surgery. | length |
| Deep incisional and organ/space sternal-surgical site infection (s-SSI) | up to 90 days after surgery | using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions |
| Acute kidney injury | within 7 days of surgery | Based on serum creatinine, following Acute Kidney Injury Network definition |
| Pain on day 7 | Pain at Day 7 (+/- 1 day) | Visual analog scale (VAS) |
| Wound dehiscence | up to 90 days after surgery | using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions |
| C. difficile infection | up to 90 days after surgery | laboratory confirmed |
Countries
Canada
Outcome results
None listed